QA Automation Engineer

Bachelor’s degree in Computer Science, Engineering, or equivalent experience preferred
3-5 years of quality experience ideally with a software as a medical device
Experience with fast-paced agile product development using JIRA
Excellent command of the English language with ability to draft and revise QMS documents with consistency of format and language.
A passion for quality assurance and experience building BDD test cases and scenarios
Experience automating full test suites with Cypress.io and/or other modern test frameworks
Prior usage of JMeter and Postman or equivalent tools
Solid knowledge of Javascript and SQL
Experience with vulnerability testing and cybersecurity
Experience testing SaaS applications in the cloud, preferably using AWS
Demonstrable ability to drive and measure quality metrics
Passion for working in a start-up company culture
Capability to document regulatory compliant verification test protocols and reports prior to regulatory submissions and product launch to ensure software fulfills functional requirements and meets user needs

Maintaining and confirming the quality of Cleerly’s products and ensuring that the medical device conforms to and complies with company requirements, international standards, and federal regulations
Working closely with data science and product development teams to identify risks, design and implement risk management and mitigation strategies
Identifying software issues and tracking resolutions
Participating in hazard analysis and developing and improving test strategies
Developing the test plan and test cases for a new feature
Automating the world with Cypress.io or another framework
Contributing to our CI/CD pipeline and capabilities
Building complex test data sets
Manual test case execution
Participating in hazard analysis in compliance with ISO 14971
Exploratory testing of the application
Building a load testing suite for our backend systems
Testing backend APIs and services in a distributed system environment
Performing code reviews and driving bug triage
Participating in sprint planning and design meetings to help deliver quality at the earliest stages

Prior work history in Digital Health
Experience with Quality Systems pertaining to software as a medical device (SaMD)
Knowledge of ISO13485, 21 CFR 820, IEC 62304, ISO 14971, and AAMI TIR45
Experience conducting post-market surveillance activities, including field issue evaluation, complaint investigations, CAPAs, and NC
Strong understanding of risk management in medical device design, software development in product development, and post-market surveillance
Previous experience automating E2E across a distributed system